Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC

Study Summary

Multicenter, randomized, controlled, open-label, Phase 3 study designed to demonstrate that neladalkib (NVL-655) is superior to alectinib in prolonging progression-free survival (PFS) in patients with treatment-naïve, Anaplastic Lymphoma Kinase (ALK) positive, advanced Non-Small Cell Lung Cancer (NSCLC).

Conditions

Non-small Cell Lung Cancer Anaplastic Lymphoma Kinase-positive

Interventions / Drugs

Neladalkib (NVL-655)Alectinib

View on ClinicalTrials.gov ↗

Sponsor

Study Details

Enrollment450 participants

Primary Completion—

Lead SponsorNuvalent Inc.

Data Retrieved2026-04-11 04:23:07.450441+00:00

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